Clinical Trial Results:
A phase III, randomized, open-label, multicentre study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course at 2-4-6 months of age in healthy infants in South Korea.
Summary
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EudraCT number |
2012-004137-16 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
24 Feb 2012
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Results information
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Results version number |
v3(current) |
This version publication date |
16 Sep 2018
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First version publication date |
02 Jul 2015
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Other versions |
v1 (removed from public view) , v2 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
114260
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01309646 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Mar 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
24 Feb 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Feb 2012
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate that the immunogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine administered at 2, 4 and 6 months of age is non-inferior to that of the concomitant administration of GSK Biologicals’ DTPa-IPV and Hib vaccines, in terms of immune response to all vaccine antigens, one month after the third dose of the primary vaccination.
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Protection of trial subjects |
All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for one month (minimum 30 days) following administration of the last dose of study vaccines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Mar 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Korea, Republic of: 451
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Worldwide total number of subjects |
451
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
451
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
Initially, a total of 454 subjects were enrolled in the study but 3 subjects had withdrawn therefore, a total of 451 subjects were enrolled in the study. During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | |||||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Infanrix-IPV+Hib Group | |||||||||
Arm description |
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix at 6 weeks and 3.5 months of age. The Infanrix-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix vaccine was administered intramuscularly in the left thigh and the Rotarix vaccine was administered orally. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Infanrix-IPV+Hib
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Investigational medicinal product code |
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Other name |
DTPa-IPV/Hib
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular, 3 doses at 2,4 and 6 months of age.
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Investigational medicinal product name |
Synflorix
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Investigational medicinal product code |
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Other name |
10Pn-PD-DiT
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular, 3 doses at 6 weeks, 3.5 and 5.5 months of age.
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Investigational medicinal product name |
Rotarix
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Investigational medicinal product code |
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Other name |
HRV
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Pharmaceutical forms |
Powder and solvent for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Oral, 2 doses at 6 weeks and 3.5 months of age.
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Arm title
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Infanrix IPV Group | |||||||||
Arm description |
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix IPV and Hiberix co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix at 6 weeks and 3.5 months of age. The Infanrix IPV was administered intramuscularly in the right thigh, the Synflorix and Hiberix vaccines were administered intramuscularly in the left thigh and the Rotarix vaccine was administered orally. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Infanrix IPV
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Investigational medicinal product code |
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Other name |
DTPa-IPV
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular, 3 doses co-administered at 2, 4 and 6 months of age with Hiberix.
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Investigational medicinal product name |
Hiberix
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Investigational medicinal product code |
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Other name |
Hib
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular, 3 doses co-administered at 2, 4 and 6 months of age with Infanrix IPV.
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Investigational medicinal product name |
Synflorix
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Investigational medicinal product code |
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Other name |
10Pn-PD-DiT
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular, 3 doses at 6 weeks, 3.5 and 5.5 months of age.
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Investigational medicinal product name |
Rotarix
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Investigational medicinal product code |
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Other name |
HRV
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Pharmaceutical forms |
Powder and solvent for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Oral, 2 doses at 6 weeks and 3.5 months of age.
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Baseline characteristics reporting groups
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Reporting group title |
Infanrix-IPV+Hib Group
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Reporting group description |
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix at 6 weeks and 3.5 months of age. The Infanrix-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix vaccine was administered intramuscularly in the left thigh and the Rotarix vaccine was administered orally. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix IPV Group
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Reporting group description |
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix IPV and Hiberix co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix at 6 weeks and 3.5 months of age. The Infanrix IPV was administered intramuscularly in the right thigh, the Synflorix and Hiberix vaccines were administered intramuscularly in the left thigh and the Rotarix vaccine was administered orally. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Infanrix-IPV+Hib Group
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Reporting group description |
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix at 6 weeks and 3.5 months of age. The Infanrix-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix vaccine was administered intramuscularly in the left thigh and the Rotarix vaccine was administered orally. | ||
Reporting group title |
Infanrix IPV Group
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Reporting group description |
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix IPV and Hiberix co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix at 6 weeks and 3.5 months of age. The Infanrix IPV was administered intramuscularly in the right thigh, the Synflorix and Hiberix vaccines were administered intramuscularly in the left thigh and the Rotarix vaccine was administered orally. |
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End point title |
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies | |||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL). The Month 5 results are the primary outcome variables.
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End point type |
Primary
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End point timeframe |
At Month 0 and Month 5
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Statistical analysis title |
Difference in seroprotection rates for anti-D | |||||||||||||||||||||
Statistical analysis description |
To demonstrate that the immunogenicity of the Infanrix-IPV+Hib vaccine administered at 2, 4 and 6 months of age was non-inferior to that of the concomitant administration of the Infanrix IPV and Hiberix vaccines, in terms of immune response to all vaccine antigens, one month after the third dose of the primary vaccination.
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Comparison groups |
Infanrix IPV Group v Infanrix-IPV+Hib Group
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Number of subjects included in analysis |
430
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | |||||||||||||||||||||
Method |
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Parameter type |
Difference in seroprotection rate | |||||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
-1.74 | |||||||||||||||||||||
upper limit |
1.78 | |||||||||||||||||||||
Notes [1] - UL of the standardized asymptotic 95% CI on the group difference [Infanrix-IPV+Hib Group minus Infanrix IPV Group]in percentage of seroprotected subjects ≤ 10% |
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Statistical analysis title |
Difference in seroprotection rates for anti-T | |||||||||||||||||||||
Statistical analysis description |
To demonstrate that the immunogenicity of the Infanrix-IPV+Hib vaccine administered at 2, 4 and 6 months of age was non-inferior to that of the concomitant administration of the Infanrix IPV and Hiberix vaccines, in terms of immune response to all vaccine antigens, one month after the third dose of the primary vaccination.
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Comparison groups |
Infanrix-IPV+Hib Group v Infanrix IPV Group
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Number of subjects included in analysis |
430
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [2] | |||||||||||||||||||||
Method |
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Parameter type |
Difference in seroprotection rate | |||||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
-1.74 | |||||||||||||||||||||
upper limit |
1.78 | |||||||||||||||||||||
Notes [2] - UL of the standardized asymptotic 95% CI on the group difference [Infanrix-IPV+Hib Group minus Infanrix IPV Group]in percentage of seroprotected subjects ≤ 10% |
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End point title |
Number of seroprotected subjects for anti-polyribosyl-ribitol-phosphate (anti-PRP) antibodies | |||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). The Month 5 results are the primary outcome variables.
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End point type |
Primary
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End point timeframe |
At Month 0 and Month 5
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Statistical analysis title |
Difference in seroprotection rates for anti-PRP | |||||||||||||||
Statistical analysis description |
To demonstrate that the immunogenicity of the Infanrix-IPV+Hib vaccine administered at 2, 4 and 6 months of age was non-inferior to that of the concomitant administration of the Infanrix IPV and Hiberix vaccines, in terms of immune response to all vaccine antigens, one month after the third dose of the primary vaccination.
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Comparison groups |
Infanrix-IPV+Hib Group v Infanrix IPV Group
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Number of subjects included in analysis |
430
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [3] | |||||||||||||||
Method |
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Parameter type |
Difference in seroprotection rate | |||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-1.74 | |||||||||||||||
upper limit |
1.78 | |||||||||||||||
Notes [3] - UL of the standardized asymptotic 95% CI on the group difference [Infanrix-IPV+Hib Group minus Infanrix IPV Group] in percentage of seroprotected subjects ≤ 10% |
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End point title |
Concentrations for anti-D and anti-T antibodies [4] | ||||||||||||||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
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End point type |
Primary
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End point timeframe |
At Month 0 and Month 5
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of subjects seroprotected for anti-Polio virus type 1, 2 and 3 antibodies | ||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
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End point type |
Primary
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End point timeframe |
At one month after (POST) Dose 3
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Statistical analysis title |
Difference in seroprotection rates for anti-Polio1 | ||||||||||||||||||
Statistical analysis description |
To demonstrate that the immunogenicity of the Infanrix-IPV+Hib vaccine administered at 2, 4 and 6 months of age was non-inferior to that of the concomitant administration of GSK Biologicals’ Infanrix IPV and Hiberix vaccines, in terms of immune response to anti-Polio type 1 antibodies, one month after the third dose of the primary vaccination.
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Comparison groups |
Infanrix IPV Group v Infanrix-IPV+Hib Group
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Number of subjects included in analysis |
428
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [5] | ||||||||||||||||||
Method |
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Parameter type |
Difference in seroprotection rates | ||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
-1.75 | ||||||||||||||||||
upper limit |
1.78 | ||||||||||||||||||
Notes [5] - The upper limits of the standardized asymptotic 95% confidence interval (CI) on the group differences [Infanrix IPV Group minus Infanrix-IPV+Hib Group] in percentages of subjects seroprotected against poliovirus type 1 was ≤ 10%. |
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Statistical analysis title |
Difference in seroprotection rates for anti-Polio2 | ||||||||||||||||||
Statistical analysis description |
To demonstrate that the immunogenicity of the Infanrix-IPV+Hib vaccine administered at 2, 4 and 6 months of age was non-inferior to that of the concomitant administration of GSK Biologicals’ Infanrix IPV and Hiberix vaccines, in terms of immune response to anti-Polio type 2 antibodies, one month after the third dose of the primary vaccination.
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Comparison groups |
Infanrix-IPV+Hib Group v Infanrix IPV Group
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Number of subjects included in analysis |
428
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [6] | ||||||||||||||||||
Method |
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Parameter type |
Difference in seroprotection rates | ||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
-1.79 | ||||||||||||||||||
upper limit |
1.85 | ||||||||||||||||||
Notes [6] - The upper limits of the standardized asymptotic 95% confidence interval (CI) on the group differences [Infanrix IPV Group minus Infanrix-IPV+Hib Group] in percentages of subjects seroprotected against poliovirus type 2 was ≤ 10%. |
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Statistical analysis title |
Difference in seroprotection rates for anti-Polio3 | ||||||||||||||||||
Statistical analysis description |
To demonstrate that the immunogenicity of the Infanrix-IPV+Hib vaccine administered at 2, 4 and 6 months of age was non-inferior to that of the concomitant administration of GSK Biologicals’ Infanrix IPV and Hiberix vaccines, in terms of immune response to anti-Polio type 3 antibodies, one month after the third dose of the primary vaccination.
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Comparison groups |
Infanrix IPV Group v Infanrix-IPV+Hib Group
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Number of subjects included in analysis |
428
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [7] | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
Difference in seroprotection rates | ||||||||||||||||||
Point estimate |
-0.5
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Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
-3.14 | ||||||||||||||||||
upper limit |
1.89 | ||||||||||||||||||
Notes [7] - The upper limits of the standardized asymptotic 95% confidence interval (CI) on the group differences [Infanrix IPV Group minus Infanrix-IPV+Hib Group] in percentages of subjects seroprotected against poliovirus type 3 was ≤ 10%. |
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End point title |
Anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN) antibody concentrations | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At one month after (POST) Dose 3
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Statistical analysis title |
Difference in GMC ratio for anti-PT | |||||||||||||||||||||
Statistical analysis description |
To demonstrate that the immunogenicity of the Infanrix-IPV+Hib vaccine administered at 2, 4 and 6 months of age was non-inferior to that of the concomitant administration of GSK Biologicals’ Infanrix IPV and Hiberix vaccines, in terms of immune response to anti-PT antigens, one month after the third dose of the primary vaccination.
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Comparison groups |
Infanrix IPV Group v Infanrix-IPV+Hib Group
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Number of subjects included in analysis |
430
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [8] | |||||||||||||||||||||
Method |
ANCOVA | |||||||||||||||||||||
Parameter type |
Difference in GMC ratio | |||||||||||||||||||||
Point estimate |
1.04
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Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
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|||||||||||||||||||||
lower limit |
0.93 | |||||||||||||||||||||
upper limit |
1.15 | |||||||||||||||||||||
Notes [8] - The upper limits of the 95% confidence interval (CI) on the group ratio [Infanrix IPV Group divided by Infanrix-IPV+Hib Group] of geometric mean concentrations (GMCs) of antibodies against pertussis toxoid (PT) was ≤ 1.5. |
||||||||||||||||||||||
Statistical analysis title |
Difference in GMC ratio for anti-FHA | |||||||||||||||||||||
Statistical analysis description |
To demonstrate that the immunogenicity of the Infanrix-IPV+Hib vaccine administered at 2, 4 and 6 months of age was non-inferior to that of the concomitant administration of GSK Biologicals’ Infanrix IPV and Hiberix vaccines, in terms of immune response to anti-FHA antigens, one month after the third dose of the primary vaccination.
|
|||||||||||||||||||||
Comparison groups |
Infanrix-IPV+Hib Group v Infanrix IPV Group
|
|||||||||||||||||||||
Number of subjects included in analysis |
430
|
|||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||
Analysis type |
non-inferiority [9] | |||||||||||||||||||||
Method |
ANCOVA | |||||||||||||||||||||
Parameter type |
Difference in GMC ratio | |||||||||||||||||||||
Point estimate |
1.08
|
|||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||
lower limit |
0.97 | |||||||||||||||||||||
upper limit |
1.21 | |||||||||||||||||||||
Notes [9] - The upper limits of the 95% confidence interval (CI) on the group ratio [Infanrix IPV Group divided by Infanrix-IPV+Hib Group] of geometric mean concentrations (GMCs) of antibodies against filamentous haemagglutinin (FHA) was ≤ 1.5. |
||||||||||||||||||||||
Statistical analysis title |
Difference in GMC ratio for anti-PRN | |||||||||||||||||||||
Statistical analysis description |
To demonstrate that the immunogenicity of the Infanrix-IPV+Hib vaccine administered at 2, 4 and 6 months of age was non-inferior to that of the concomitant administration of GSK Biologicals’ Infanrix IPV and Hiberix vaccines, in terms of immune response to anti-PRN antigens, one month after the third dose of the primary vaccination.
|
|||||||||||||||||||||
Comparison groups |
Infanrix-IPV+Hib Group v Infanrix IPV Group
|
|||||||||||||||||||||
Number of subjects included in analysis |
430
|
|||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||
Analysis type |
non-inferiority [10] | |||||||||||||||||||||
Method |
ANCOVA | |||||||||||||||||||||
Parameter type |
Difference in GMC ratio | |||||||||||||||||||||
Point estimate |
1.08
|
|||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||
lower limit |
0.96 | |||||||||||||||||||||
upper limit |
1.21 | |||||||||||||||||||||
Notes [10] - The upper limits of the 95% confidence interval (CI) on the group ratio [Infanrix IPV Group divided by Infanrix-IPV+Hib Group] of geometric mean concentrations (GMCs) of antibodies against pertactin (PRN) was ≤ 1.5. |
|
|||||||||||||||||||
End point title |
Number of subjects with any solicited local symptoms | ||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix-IPV+Hib or Infanrix IPV + Hiberix
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with any solicited general symptoms | |||||||||||||||||||||
End point description |
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix-IPV+Hib or Infanrix IPV + Hiberix
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with any unsolicited adverse events (AEs) | ||||||||||||
End point description |
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix-IPV+Hib or Infanrix IPV + Hiberix
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with any serious adverse events (SAEs) | ||||||||||||
End point description |
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the entire study period (from Month 0 to Month 7)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Concentrations of anti-PRN antibodies | ||||||||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
At Month 0 and Month 5
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Concentrations of anti-PRP antibodies | ||||||||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
At Month 0 and Month 5
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects with a vaccine response to anti-PT, anti-FHA and anti-PRN. | ||||||||||||||||||
End point description |
Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
At Month 5
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of seroprotected subjects for anti-Polio type 1, 2 and 3 | ||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres greater to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Prior to vaccination (PRE)
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Anti-Polio type 1, 2 and 3 antibody titers | ||||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Prior to vaccination (PRE) and one month after (POST) Dose 3
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of seropositive subjects for anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN). | |||||||||||||||||||||||||||
End point description |
A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL).
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
At Month 0 and Month 5
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Anti-PT, anti-FHA and anti-PRN antibody concentrations | |||||||||||||||||||||
End point description |
||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Prior to vaccination (PRE)
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
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Reporting group title |
Infanrix IPV Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix IPV and Hiberix co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix at 6 weeks and 3.5 months of age. The Infanrix IPV was administered intramuscularly in the right thigh, the Synflorix and Hiberix vaccines were administered intramuscularly in the left thigh and the Rotarix vaccine was administered orally. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix-IPV+Hib Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix at 6 weeks and 3.5 months of age. The Infanrix-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix vaccine was administered intramuscularly in the left thigh and the Rotarix vaccine was administered orally. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |